BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2780009 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12112
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    June 12, 2012
    Report Date
    September 4, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED DURING A OPEN HEART PROCEDURE. THE LEAD WAS SEWN BACK INTO PLACE BY THE SURGEON AND A LEAD REVISION WAS TO BE PERFORMED UPON THE PATIENT RECOVERING FROM THE OPEN HEART PROCEDURE. IT WAS NOTED THAT THE PATIENT EXPIRED TWO MONTHS LATER AND THE PHYSICIAN STATED THE DEATH WAS NOT DUE TO THE RA LEAD ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0158| H170| 4086| N119| 4193